Spinal Cord Stimulation for Orthostatic Hypotension

Orthostatic Hypotension Clinical Trial

Official title:

Hemodynamic Effects of Transcutaneous Spinal Cord Stimulation During Passive Orthostasis: a Prospective Single-center Randomized Cross-over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05230147
• Other study ID #: Ortho-stim_2022
• Status: Completed
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective single-center randomized crossover control study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation in patients with known or suspected orthostatic hypotension.

Description:

The hypothesis is that transcutaneous spinal cord stimulation at thoracic level may correct hypotensive episodes during tilt testing in subjects with blood pressure drops.

Eligible patients will sign an informed consent form before the procedure. Non-invasive transcutaneous electrical stimulation of the spinal cord will be applied using modulated electrical impulses through external adhesive electrode patches connected to a neural stimulator device. The study protocol includes analysis of the following parameters: heart rate; 12-lead electrocardiogram; continuous beat-to-beat blood pressure recordings (measured noninvasively by plethysmography) before stimulation, during stimulation and after spinal cord stimulation. All registered data will be analyzed at the end of the procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2024
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age 18-85 years

2. Suspected orthostatic hypotension (having a history of syncope and/or pre-syncope that occurred during the transition to an upright position, with complaints of recurrent dizziness that occurs during the transition to an upright position) or documented orthostatic hypotension.

3. The patient who signed the informed consent form

Exclusion Criteria:

1. Orthostatic hypotension caused by acute hypovolemia or bleeding.

2. Chronic heart failure III-IV functional class (NYHA)

3. Structural heart disease of the following: hypertrophic cardiomyopathy with obstruction of the left ventricular outflow tract, acute coronary syndrome, restrictive cardiomyopathy, hemodynamically significant valvular heart defects, uncorrected hemodynamically significant congenital heart defects.

4. Ongoing acute illness.

5. >90% paced cardiac rhythm.

6. Permanent atrial fibrillation.

7. A history of transient ischemic attack or stroke within 3 months before the enrollment and/or incomplete recovery.

8. Pulmonary embolism <1 month ago.

9. Epilepsy.

10. The presence of an implantable pump.

11. Patients with contraindications to the use of the patch electrodes used in this study, as indicated in the relevant instructions for use.

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension

Intervention

Procedure:
• Spinal cord stimulation
Single stimuli are delivered to define the stimulation threshold. High-frequency stimulation with modulated current via skin patches captures posterior horns of the spinal cord.
• Sham stimulation
Single stimuli are delivered to define the stimulation threshold. High-frequency stimulation is not delivered.

Locations

Country	Name	City	State
Russian Federation	Almazov National Medical Research Centre	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

Lobov GI, Gerasimenko YP, Moshonkina TR. Mechanisms of Blood Flow Regulation in the Skin during Stimulation of the Spinal Cord in Humans. Dokl Biol Sci. 2019 Mar;485(1):27-29. doi: 10.1134/S0012496619020030. Epub 2019 Jun 13. — View Citation

Mikhaylov EN, Moshonkina TR, Zharova EN, Garkina SV, Kovzelev PD, Belyaeva NN, Kozlenok AV, Lebedev DS, Shlyakhto EV. Acute Cardiovascular Effects of Non-Invasive Electrical Spinal Cord Stimulation: Results from a Pilot Study in Humans. J Cardiovasc Transl Res. 2020 Dec;13(6):891-893. doi: 10.1007/s12265-020-10014-7. Epub 2020 May 6. — View Citation

Phillips AA, Squair JW, Sayenko DG, Edgerton VR, Gerasimenko Y, Krassioukov AV. An Autonomic Neuroprosthesis: Noninvasive Electrical Spinal Cord Stimulation Restores Autonomic Cardiovascular Function in Individuals with Spinal Cord Injury. J Neurotrauma. 2018 Feb 1;35(3):446-451. doi: 10.1089/neu.2017.5082. Epub 2017 Nov 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure drop correction	It is suggested that spinal cord stimulation will correct systolic blood pressure drop during tilt testing. The effect is expected within 5-10 mmHg as a difference between minimum systolic blood pressure during stimulation and without stimulation (sham).	5-30 minutes following verticalization
Secondary	Diastolic blood pressure drop correction	It is suggested that spinal cord stimulation will correct diastolic blood pressure drop during tilt testing. The effect is expected within 5-10 mmHg as a difference between minimum diastolic blood pressure during stimulation and without stimulation (sham).	5-30 minutes following verticalization